Musings in the life of an internist, cardiologist and cardiac electrophysiologist.

Friday, June 15, 2007

Patient-Laundered Direct-to-Consumer Advertising

Direct-to-consumer advertising took a new turn today.

I received this press release for a new website, called StopAfib.org. I follow atrial fibrillation therapies and developments pretty closely, I think, for obvious reason: it's what I do. So when I saw this site I decided to check it out.

The website is nicely executed. It seems to have been sponsored by a patient who experienced what sounds like a transient ischemic attack, or stroke, seven months after having emergency heart surgery. She was, the site says, "intrigued by the potential of pulmonary vein isolation to eliminate her atrial fibrillation, and especially fascinated that the removal of the left atrial appendage could eliminate her stroke risk." Really? Would Ms. Hill even know what a left atrial appendage is?

A closer inspection to the press release confirms that the site is being marketed by a website developer and marketer to the elective healthcare industry:

Founded in 2002, and based in San Luis Obispo, California, Etna Interactive provides Web marketing services to the elective healthcare industry (including medical device manufacturers, plastic surgeons, cosmetic surgeons, surgeons and medical day spas); to physicians and surgeons offering new or novel treatments; and to professional service providers including lawyers, architects and builders. Etna Interactive services clients from Hawaii to upstate New York.

What is interesting is that this company recognized the need to skirt the provisions of Section 650 of the Medical Board of California Business and Professions Code that forbids "fees for referrals."

And yet, close inspection of the one and only advertiser on this website is Atricure, Inc., the company interested in marketing their equipment for open-chest pulmonary vein isolation for atrial fibrillation. Further more, look at Ms. Mellanie Hill's storycarefully.

On September 13, 2005, Mellanie had Mini-Maze surgery with the AtriCure bipolar (RF) device and says, "Though it was surgery, with risks and anesthesia, and was in an area that is very delicate for women, I have no regrets." She had been grounded from flying for two years, and was now able to fly again and travel by herself. She says, "You can't put a price on getting your freedom back."

Would a patient really know (or care) that her surgery was performed with the "Atricure bipolar (RF) device?" Does the patient know what "bipolar" means? Or what "(RF)" means?

It is clear this site has been developed by a marketing department of a medical device company. Like industry-paid ghost writers in medical journals, this new tactic is disturbing. Has Atricure has used a website developer and gullible patient to ghost write the marketing of their medical devices? Worse still, could this patient who has had a stroke (or transient ischemic attack) and might be at high risk of recurrent stroke, even after her ablation, be making potenially dangerous recommendations (that stopping warfarin is OK), all in the interest of marketing? And when does a patient testimonial platform that is funded by a company become a "fee for referral" for that company's devices?

While I have nothing against patients standing up for a cause they believe in, I just wish they'd do it themselves. If the StopAfib.org site wants to accomplish this goal:

We're not pushing products or services, or selling anything. We want this site to be as unbiased and informational as possible.

...then they'd better develop their site themselves.

-Wes

15:15PM CST Addendum: I contacted Ms. Hill regarding this post and she was very nice to respond. She did confirm that Atricure contacted her first and had a particular interest in her skills as an "author, writer, and speaker," and they shared ideas and it was her idea to provide a forum for patients to explain options for atrial fibrillation therapies and ways to prevent strokes. Hence they provided a grant to her. She states Atricure was "very careful" to remain detached from the project. She also noted the "EP's had a vested interest" in performing catheter-based afib ablation procedures and often refused to refer patients for surgical procedures. She is continuing to seek other sponsors for her website.

Thanks for calling me to find out more about StopAfib.org. I returned your call as soon as I received it, which was in less than 2 hours. I do wish we'd spoken before you posted your original comments, but thanks for your corrections.

I would appreciate the opportunity to set the record straight - I wrote EACH and EVERY word on StopAfib.org and have invested countless hours of my personal time in researching and writing. I guess, however, that I should feel very honored that you thought it was professional enough to have come from industry ghostwriters. However, that's absolutely not the case. I couldn't even afford to have an editor review the content, so I edited it all myself. Perhaps if you spend more time there you will see that it was not ghostwritten at all and is truly an unbiased, patient-centric view written by a patient.

By the way, yes, I do know a left atrial appendage from a pulmonary vein, and from my pre-surgery research I do care very much what type of energy source was used. I do, in fact, know what RF is, and can even tell a resistor from a transistor (I was raised by an electrical engineer and am married to one, as well). And yes, I know unipolar from bipolar. I happen to be a scientist by training (undergrad & grad).

One further clarification - AtriCure gave me a grant to build this site so it would be professional enough that I could attract other sponsors. (AtriCure is a sponsor, not an advertiser - we don't take advertising.) I used the grant to pay for web development so the site would be professional. I do believe that you owe AtriCure an apology for your comments.

This site is my mission - to eliminate strokes caused by afib. I have seen the devastation of stroke among several of my friends, and believe that we can wipe it out.

Unfortunately, your comments make it sound like you don't think of patients as being intelligent. Please take some time to hang out in some of the afib groups online - you'll be stunned by how smart most afib patients there are. Some of them just happen to also be medical personnel. Afib patients do a whole lot of research and are extremely educated.

Thanks for the opportunity to clarify that StopAfib.org is my own project in my own words, not the work of a medical device company. I will continue, however, to feel honored that you could possibly mistake it as such.

There are a couple of additional facts in your comments that are very concerning, so let me address them:

1) I did not have either a stroke or a TIA, though I did have a close call with stroke due to blood clots. It was my Electrophysiologist who took me off of Coumadin(R) 3 months following surgery after a month of monitoring showed no further afib. I don't recommend that folks stop Coumadin, and in fact, am very clear on StopAfib.org that I am not offering medical advice. I very clearly recommend that afib patients discuss their concerns with their physicians.

2) Contrary to your statement, my site, StopAfib.org, is not being marketed by a web developer. The CEO of our web developer, Etna Interactive, believes so strongly in my crusade that he was kind enough to send a press release to help me get the word out to afib patients about the site. I think, therefore, that the folks at Etna Interactive also deserve an apology for the false conclusion that unfairly maligned them.

I am very disappointed, and yes, even hurt, that you felt it necessary to publicly malign me without getting the facts before publishing your comments, and that you did the same to two innocent companies. In speaking with me, you didn't mention your comments that you had already posted in your blog. I appreciate you posting an addendum, but would appreciate your correcting the many inaccuracies that still remain. Thanks for allowing me to set the record straight.

Now that this article is showing up around the web without the Addendum, I request that you either set the record completely straight or pull this article completely from your blog and stop it from circulating. This article is absolutely NOT TRUE.

This article also questions my integrity. My integrity is everything, and it is not for sale!

If you cannot set the record completely straight, then please remove this article completely.

MH-Could you clarify a few statements from your website-you state that with regards to catheter ablation "success to date in curing afib (sp) has been very low, but has been improving at centers with large numbers of procedures accomplished. ... With catheter ablation there is less control by the EP because catheters are threaded through the blood vessels(,) and thus there is no direct visibility of what is happening. That has resuled in a high level of complications to date, so catheter ablation risks are a significant factor in undertaking this procedure."

Could you elaborate on what you consider low success rates and high level of complications?

Also could you elaborate of success rate and complication rate of Mini-Maze?

Your post stirred up a lot of feelings for me this weekend. I felt sad for Ms. Hills, who gives so much of her time, energy, and money to educate men and women about heart health issues and treatment options. I was angered about your allegations that we are coaching doctors to skirt California's Business & Professions Code. I was disappointed in the inaccuracies in your post and the way you insulted patients everywhere.

But giving myself a few days to think it over, I realized that you actually meant well. You were wearing a hat that I try on all the time, you were working as a watch dog for your peers and patients.

But you failed to do basic fact checking and as a result defamed Mrs. Hills, referenced our release out of context, made false statements about my company, insulted the intelligence of afib sufferers everywhere. Worse, without knowing it, I think you demonstrated just why we need people like Melanie True Hills. In assuming that no patientcould understand something as simple as a pocket inside the heart where blood might pool and clot, you suggested that you yourself are guilty of not informing your afib patients about the risks of "living" with afib.

Will you permit me to offer some additional information about our role in the development of stopafib.org? Here are some facts to add to your blog:

1. Etna Interactive authored none of the content featured at stopafib.org

2. My company did create the design and construct the site for Mrs. Hills' foundation (thank you by the way for the "well executed" remark)

3. We were so inspired by her story that we donated thousands of dollars of our time to cover part of the cost of the site's development

I would also like to correct your remark about our position on California's Business & Professions Code. I am grateful that you linked to our release regarding the Medical Board of California's Business and Professions Code section 650. That particular issue is of great concern to our organization. I had hoped that the release would trigger greater dialogue of the topic, but I fear you are the first to pick up the story (and then, out of context).

The fact is several marketing companies had approached our clients attempting to sell them "pay-per-lead" programs. We felt these were illegal and advised our clients NOT to participate. We went even further, reporting these firms to the Medical Board of California. My experience has been that state medical licensing boards do not activelypolice such programs, but rather only respond to letters of complaint. So, we published the release as a warning to California's clinical community. The purpose of the release was not to coach medical professionals to skirt the code as your suggest, but to advise clinicians to stay away from "pay-per-lead" programs. It would be great if you covered this topic in a future post on your blog.

And regarding whether or not Mrs. Hills would know about the left atrial appendage, shame on you doctor. It's certainly not my desire to speak for her, but I will say that today, more times than not, patients are very informed of all aspects of a surgical procedure; we see evidence of this fact everyday during our interviews with patients. Afib is, after all, life and death we're talking about, and patients want - and deserve - to know as much as possible about what they're up against, who can help, and how. Unfortunately, many doctors simply lack the time toeducate patients. Fortunately, that doesn't stop patients like Mrs. Hills from finding the answers they need and then sharing that information with others.

I know you really did mean well with your original post. But you owe Mrs. Hills an apology, my organization a correction, and your patients a bit more respect.

I'm on the patient end of things, not the medical care end, but I have enough contact with doctors (family members, medical blogs) to have it impressed upon me the degree to which doctors think of "patients" as stupid. Perhaps individual patients are bright and thoughtful, and as such are likely to be mentioned if the doctor develops a relationship with them, but in the abstract - stupid. At best ignorant, at worst malicious.

I understand that this conception developed over years of actual work with actual patients, and that when doctors educate their patients they must not make any assumptions about what they know and understand - it may be stunningly little.

But the conception of "patient" varies with perspective. For instance, if everyone who isn't a doctor is a patient, I know an awful lot of extremely sophisticated patients. Including my grandmother, a fit 83-year old woman who developed a technique for commercialising the production of penicillin in Rome in the 1950s. (Yes, she developed it. She is a PhD in mycology. She could and she did. The FAO hired her while whe was in Italy because Italy wasn't a signatory to international patent law at the time, and penicillin was under patent protection and beyond the reach of most of the world's population. So the FAO hired her to develop a commercial production technique for penicillin independently, from scratch.) Even today, my grandmother's afternoon reading consists of Nature (yes, that one) and Science News. (Her bedtime reading is more likely to be history.)

I grant that my grandmother is not a typical patient, but she is a patient. To say that "a patient" could not understand or care about any particular aspect of their care is simply incorrect. You can only make that kind of statement about a particular patient.

I agree that DTC marketing is a problem. I agree that sneakiness is both despicable and a problem. So I do agree with the substance of your post.

But I am deeply concerned about the assumptions that no patient could understand their care, that no patient cares about the technical workings of it. As soon as you get into the territory of the medical-themed blog, it seems to me that the odds of running into an educated person have exponentially increased with respect to the territory of the ED. Not acknowledging this fact simply increases the public's distrust of doctors.

In my case, it increases my fear of doctors: if my doctor assumes I am ignorant and wrong at all times and cannot understand or care about my care, then how can I advocate for myself if I believe that I am being harmed by a particular course of treatment at a particular time? Or if a doctor and I disagree about the need for agressive treatment?

To all - I regret deeply that I have not been able to respond as yet due to the fact I was away from computer access this weekend and am presently involved with patient care repsonsibilities. I will post a response to the above commentors later this evening. I appreciate your patience.

Anonymous,The passage you quoted was taken from an overview on catheter ablation. On the more detailed pages I addressed in detail the success rates and risks described in multiple studies. Rather than going into lots of details here, or pasting in pages and pages of text, please refer to these pages:

III,Regarding my scientific background, my undergraduate work was in Textile Chemistry and Physics, and my graduate work was in the same with a minor in Biostatistics. That was a long time ago, and I've developed many more important credentials since. Since that was so long ago and was totally irrelevant to my speaking and writing, I didn't bother listing it on my personal web site.

Alison,You are so right about patients. Thanks for sharing your comments. We're all patients, and many patients are very smart and highly competent. I suspect that some doctors feel threatened by their patients, but I've always been very fortunate to have found doctors that treated me as an equal partner in my health care. They loved having very informed patients, and knew I was always prepared for our visits, so they usually started off by asking "What questions are on your list today?" My doctors have truly been rare jewels.

Finally, could someone please tell me why I am being personally attacked? I'm simply a patient trying to help other patients, and attacking me doesn't make any sense. And why do you find it necessary to hide behind aliases to do so rather than signing your name?

The website claims to want to foster no attachments to any particular company or its device and attempts to justify this "belief" by stating others should submit their stories. If this is the case than why is there only one story and it only refers to one company which "sponsored" the site? The site makes use of a number of visuals to indicate that more than one "perspective" has been included which is false.

III wrote: "Which school(s) and what years did you graduate? If you claim you are a scientist, then you would not leave this information out when someone asks what your credentials are."

Obviously, you and I are coming from a different place regarding degrees. Your degrees were obviously more significant to you than mine were to me. I was never really able to use my textile chemistry and physics degrees because I discovered while working in the labs during grad school that I was allergic to many of the lab chemicals and thus could not use my degree once I got out of school. Thus, it's never been very important to me to list that credential, other than that I learned a lot in college.

However, in the interest of full transparency, both were at Auburn University, 1972 and 1977 (I think). My diplomas are still packed from our move so I can't double-check dates, and I stopped listing years on my CVs when I went into high tech. In high tech companies, being over 40 is a huge liability, and since I didn't look my age, I didn't need to give it away.

Growing up in the South, you would never ask a woman her age or anything that would divulge such personal information, so I personally feel this question is out of line. And claiming that I'm lying because I'm uncomfortable sharing personal information with the whole world is certainly stepping over the line. However, since you insist that I post for the whole world such personal details, I hope you'll have the common courtesy to at least sign your name to any subsequent posts.

Anonymous wrote: "why is there only one story and it only refers to one company which "sponsored" the site? The site makes use of a number of visuals to indicate that more than one "perspective" has been included which is false."

Contrary to your presumptions, there is nothing sinister here. There is currently only one story because since bringing up the site I have moved across the state and was also on the road almost constantly for Stroke Month. Thus, I have had no personal time to write up the stories that have come in or for which I've done interviews. I have a bunch to write up, and that's on my personal to-do list, but I will be traveling more over the next few weeks and will fit it in as best I can.

Regarding the visuals: in working with the web developer I realized just how expensive it is to license medical visuals. (You'd be shocked.) AtriCure was willing to let me use some of theirs, which are freely available on their site for the whole world to use. Neither I, nor our foundation, can afford to pay for things where a less expensive option is available.

I will reiterate – I am talking with others about sponsorship. If you have connections to a company that would be appropriate, please let me know.

This is not a project of any medical device company – it is my personal work, and if I hadn't had to waste so much time trying to clear my name, I could have gotten some of those stories written up.

Advanced Medical Technology Association (AdvaMed), to which Atricure belongs, is the largest medical technology association in the world. Headquartered in Washington, DC, Advamed is a medical industry lobbying organization that represents more than 1100 manufacturers of medical devices, diagnostic products, and medical information systems. AdvaMed members manufacture 90% of $75 billion worth of heath care technology products purchased in the United States each year, and more than half of the $175 billion in medical technology sold annually worldwide.

On Sept 3, 2003, AdvaMed adopted its Code of Ethics on Interactions with Health Care Professionals. The AdvaMed member organizations realized that “ethical standards and compliance with applicable laws are critical to the medical device industry’s ability to continue its collaboration with Health Care Professionals (HCPs). As such AdvaMed adopted its voluntary Code of Ethics to facilitate ethical interations with HCPs, or ‘those individuals or entities that purchase, lease, recommend, use, arrange for the purchase or lease of, or prescribe Member’s medical technology products in the U.S.’”

Financial relationships between physicians and corporations are held to a high standard: specific guidelines for gifts to physicians (must serve a genuine educational function and have a fair market value of less than $100) and charitable donations were outlined:

Members may make charitable donations to charitable organizations for a charitable purpose, such as independent medical research, indigent care, patient education and public education, and sponsorship of events where proceeds are charitable.

Unfortunately, no such Code exists for the AdvaMed members’ dealings with patients. While reviewing the Code further, I identified only one statement regarding gifts to individuals (Page 5): “Donations should only be made to charitable organizations or, in rare instances, to individuals engaged in genuine charitable missions for the support of that mission.” Herein lays my concerns with what happened with the StopAfib.org website. I certainly have no beef with patients telling their story, offering advice or support to others with similar ailments, linking to informative or helpful information – this is what the internet is about after all. But when patients use their forum to discuss health care issues representing their sponsor’s products by name, rather than in principle, they open themselves to criticism as “potentially biased.”

AdvaMed sets a standard here that the medical consumer should not ignore. A medical device company has given what seems to have been a “grant” in excess of $100 (disclaimer: I do NOT know the actual amount) to develop a highly sophisticated website to an individual patient, Ms. Mellanie Hills. I contacted her and confirmed that they contacted her first. She, it seems, did not solicit Atricure for the grant independently. In my view, this is marketing, advertising, collusion with patients, and although I am not a lawyer, perhaps even illegal.

Likewise, when a web developer (ETNA Interactive) pays for a press release on PRWEB.com for a website that they developed with the funds from the same medical technology company grant in association with “thousands of dollars” - are they not advertising – both their services and those of the website they developed? I was puzzled that Mr. Miller described Mr. Hills’ efforts as a “foundation” – did I miss something? Are there other members of the foundation’s board we aren’t familiar with?

It is unfortunate that a patient (Ms. Hills) who appears to have good intentions and a reputation at stake has been subject to this event. The fact that Atricure, Inc. has opened her up to this scrutiny I am sure was unanticipated by Ms. Hills. My intent in this post was not to belittle Ms Hills’ knowledge of atrial fibrillation therapies or knowledge base or her well-meaning intentions – I regret if I sounded offensive in this regard. Patients are, after all, better informed than they ever have been, thanks to the wonders of the internet. But I take issue with industry issuing grants to individual patients for their personal agenda at a time when physicians and other health care providers are under increasing scrutiny regarding financial enticements by industry. Such double-standards cannot and should not be tolerated.

You wrote: "I was puzzled that Mr. Miller described Mr. Hills’ efforts as a “foundation” – did I miss something?"

Clearly you did!

While I personally erred in my earlier posts in not being more clear that StopAfib.org is a product of a 501(3) non-profit foundation, the American Foundation for Women's Health (http://www.americanwomenshealth.org), which is founded on patients helping patients, you erred in continuing to jump to false conclusions by missing our home page which clearly states:

"We understand what you are going through and what you are feeling. We've been there, too. Our founder, Mellanie True Hills, suffered from devastating atrial fibrillation and is now cured. We created StopAfib.org, under the auspices of the American Foundation for Women's Health, to share what she and other atrial fibrillation patients have learned and to provide you with information and answers to your questions.

"Our goal is to provide you with perspectives about living with atrial fibrillation, controlling it, and even curing it. We're about patients helping patients, providing information, education, and resources. You can conquer afib, and we're here to help you do that."

And further, on the About Us page we state:

"We hope to learn from each other. This site is a work in progress, with more content and tools to be added. Our goal is to foster communication, conversation, and collaboration. We'd love your participation in the process. We hope that you, as an afib patient, will share your own experiences here.

"This site is written by patients for patients. Since we're not doctors or trained medical personnel, we can't guarantee 100% medical accuracy. This site is no substitute for medical attention, and is meant to educate you so that you can be a proactive partner with your healthcare team in managing your atrial fibrillation together."

I feel this mission so passionately that I sometimes fail to distinguish myself from our mission, which is only natural when one intensely believes in the mission.

Again, you have crossed the line by stating that in your opinion the grant AtriCure provided was illegal. You specifically quoted from the AdvaMed code that:

"Members may make charitable donations to charitable organizations for a charitable purpose, such as independent medical research, indigent care, patient education and public education, and sponsorship of events where proceeds are charitable."

AtriCure clearly provided a grant to a 501(c)3 charitable organization for the purpose of patient education.

One other gross misstatement was that AtriCure contacted me directly. Let me reiterate –they did not seek me out directly. I specifically recall telling you that my cardiac surgeon introduced me to them when I was there for a follow-up visit after surgery as they were in the office that day and were intrigued because I was not only a patient, but was also a speaker and had written a book. Upon meeting them, I told them how grateful I was for their device that my surgeon had used to cure my afib and how it had restored my life and freedom.

I clearly do not understand what bone you have to pick with AtriCure, but I think you are being grossly unfair to them.

Again, I call for you to apologize to all involved—AtriCure, Etna Interactive, and myself—for mischaracterizing StopAfib.org and those who have so generously supported it.

I feel this mission so passionately that I sometimes fail to distinguish myself from our mission, which is only natural when one intensely believes in the mission.

Thanks for the clairifications. Unfortunately none of these facts appear on your About Us web page, do they? And here we are, the interested public and health care providers wanting to check the quality and integrity of the medical information our patients receive. Do you and Atricure not bear some of the responsibility to myself and the very patients you are attempting to serve for this omission?

You have a valid point that it's not on the About Us page, but here is why that happened:

First, since ".org" addresses are just for non-profits, I made the presumption that the address stood on its own. However, in retrospect, perhaps not everyone knows that.

Secondly, in writing the About Us page, I figured that folks would be coming from the home page and didn't redundantly state that this was under the auspices of the foundation. Most people consider repeating something over and over to be an insult to their intelligence. Perhaps, in retrospect, I should have included this redundant information; otherwise, those that want to pick things apart will obviously find any excuse to do so. Is it really necessary to continue to pick us apart?

I have admitted my errors on this blog, but is it really necessary for YOU to continue to blame ME because you jumped to false conclusions and wrote your blog BEFORE checking the facts? These personal attacks are unprofessional. Please stop them.

And finally, AtriCure had nothing to do with this. Why do you keep dragging them into this? They were generous enough to provide the foundation a grant for patient education to start carrying out our mission, and you are now unfairly maligning them for their generosity. I am politely requesting that you to leave them out of this, other than to apologize to them for defaming them.

The American Foundation for Women's health has a one-page website, that states its founder is Mellanie Hills. There's not much more info than that, except for mention of the StopAfib.org website. Interestingly, the foundation's website is also designed by Etna.

This whole situation is awfully circuitous. Frankly, from my point of view, all of this is by and for Mellanie Hills, web designed by Etna, and all made possible by money from Atricure.

Unfortunately Ms Hills is biased in her moderating along with another lady policing that site. The posters are closely scanned for any criticism of Pharmaceuticals and conventional Medicine. One such thread was locked by Ms Hills due to what she referred to as "attacking" Drug companys in a thread titled "The high cost of Meds". Some posters speaking of alternative care and cures are ridiculed in an Alensky form of intolerance. Obviously she is protecting a business and there is a serious conflict of interest on that controlled and contrived site.

About Me

Westby G. Fisher, MD, FACC is a board certified internist, cardiologist, and cardiac electrophysiologist (doctor specializing in heart rhythm disorders) practicing at NorthShore University HealthSystem in Evanston, IL, USA and is a Clinical Associate Professor of Medicine at University of Chicago's Pritzker School of Medicine. He entered the blog-o-sphere in November, 2005.
DISCLAIMER: The opinions expressed in this blog are strictly the those of the author(s) and should not be construed as the opinion(s) or policy(ies) of NorthShore University HealthSystem, nor recommendations for your care or anyone else's. Please seek professional guidance instead.